Clinical Progress in Rare Disease Signals Long-Term Revenue Potential for Innovators

NetworkNewsWire Editorial Coverage 

New York, NY – August 6, 2025 - As the American population gets older, chronic and rare diseases are becoming a significant healthcare issue, particularly for older adults. The aging population's increasing life expectancy also leads to more complex healthcare needs, especially for conditions that are both chronic and difficult to diagnose. Many of these rare conditions lack FDA-approved treatments, and their symptoms in seniors are frequently mistaken for normal signs of aging, causing diagnostic delays that can last for years. There are more than 30 million Americans who have a rare disease, so there is a growing need for accurate diagnoses and effective treatments. The Trump administration's "Make America Healthy Again" initiatives have highlighted this problem and focused on improving access to treatments and speeding up medical innovation. Soligenix Inc. (NASDAQ: SNGX) (Profile) is working to advance this mission with its HyBryte(TM) platform, a new therapy for cutaneous T-cell lymphoma (CTCL), a rare form of skin cancer that largely impacts older adults. The company has successfully established U.S.-based manufacturing for HyBryte's active ingredient, demonstrating the kind of domestic innovation that can significantly help this underserved patient group. Soligenix is one of several notable companies dedicated to making an impact in the pharmaceutical field, alongside Amgen Inc. (NASDAQ: AMGN), Amicus Therapeutics Inc. (NASDAQ: FOLD), Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) and Citius Oncology Inc. (NASDAQ: CTOR).

·         Soligenix’s HyBryte program is a promising treatment option for cutaneous T-cell lymphoma (CTCL), a rare cancer that largely impacts older adults.

·         In 2024, the global market for CTCL therapies in the seven major markets (the United States, EU4, the United Kingdom, and Japan) was estimated to be around $995 million.

·         Soligenix is conducting a second confirmatory phase 3 clinical trial for HyBryte, which is a crucial step in moving the therapy toward global commercialization.

·         One of HyBryte’s most important strengths in the treatment of cutaneous T-cell lymphoma (CTCL) is its consistently favorable safety record.

Click here to view the custom infographic of the Soligenix Inc. editorial.

Chronic Conditions Demand Targeted Innovation

Chronic rare diseases are becoming a major challenge for the aging population in the United States. As life expectancy rises, healthcare needs become more complex, especially for conditions that are long-lasting and hard to diagnose. With tens of millions of Americans living with a rare disease, many of whom are seniors whose symptoms might be dismissed as normal signs of aging, there is a clear and growing need for better care. 

Since rare diseases can present subtly or mimic common age-related issues, older adults often face diagnostic delays of years, which can hinder access to effective care and lead to worse outcomes. The problem is made worse by the limited number of FDA-approved treatments. With thousands of uncommon diseases identified, most still do not have approved therapies, which highlights the importance of ongoing investment in research and development. Seniors are particularly susceptible to underdiagnosis and undertreatment, especially when the healthcare system isn't prepared to recognize the subtle ways these conditions manifest in older adults. 

President Trump’s "Make America Healthy Again" initiative has drawn attention to the increasing burden of chronic and rare diseases. These efforts, which include policies aimed at accelerating research, improving diagnostic tools, and expanding access to care, are designed to meet the needs of older Americans facing these complicated health challenges.

Savvy companies such as Soligenix Inc. are stepping up to address this need. The company's HyBryte program is a promising treatment option for cutaneous T-cell lymphoma (CTCL), a rare cancer that largely impacts older adults. Soligenix has recently completed the successful U.S. manufacturing transfer of HyBryte’s active ingredient, which helps the company's mission to provide effective, innovative treatments to patients who need them most.

Growing CTCL Market Highlights Urgency

Cutaneous T-cell lymphoma (CTCL) is a rare type of non-Hodgkin’s lymphoma (NHL) that mainly affects the skin. Unlike other lymphomas, CTCL involves malignant T-cells that move to the skin's surface, where they form patches, lesions, or tumors. This chronic cancer is most often seen in older adults, making it particularly relevant to the aging population. Despite its rarity, CTCL is a serious medical issue, affecting over 40,000 NHL patients worldwide. 

Currently, there is no cure for CTCL, and treatments are typically focused on managing symptoms and slowing the disease's progression. Mycosis fungoides (MF) is the most common subtype of CTCL, accounting for about 90% of all cases. In its early stages (I–IIA), MF has a relatively high five-year survival rate of 88%, but it remains a lifelong illness. As a chronic condition with no approved first-line therapy for early-stage patients, CTCL represents a clear unmet medical need. 

In 2024, the global market for CTCL therapies in the seven major markets (the United States, EU4, the United Kingdom, and Japan) was estimated to be around $995 million, with the U.S. making up approximately 70% of that total. Additionally, DelveInsight notes that “the expected launch of therapies such as HyBryte . . . will also boost the CTCL market growth.” In the absence of novel therapies, treatment choices remain scarce, particularly for individuals diagnosed in the early phases of the disease. Numerous patients cycle through multiple therapies with minimal results, underscoring the urgent demand for more precise and effective treatment options.

HyBryte (synthetic hypericin) from Soligenix represents a compelling candidate to serve as a first-line treatment for early-stage CTCL. Addressing a crucial unmet need, HyBryte has the potential to greatly enhance patient well-being and emerge as a top therapeutic choice within this largely unaddressed segment of the market.

Pivotal Trial Advances Global Approval

Soligenix is currently conducting a second confirmatory phase 3 clinical trial for HyBryte, called FLASH2, which is a crucial step in moving the therapy toward global commercialization for the treatment of early-stage CTCL. The FLASH2 study is designed to confirm the positive results of the first FLASH study and has been accepted by the European Medicines Agency (EMA), with ongoing discussions with the U.S. Food and Drug Administration (FDA). The EMA's validation of the trial design shows its strength and its alignment with international standards for therapeutic approval.

The FLASH2 study is similar to its predecessor but features a longer, 18-week double-blind, placebo-controlled treatment period, which is three times longer than the original six-week period in the first FLASH trial. This extended timeline is expected to provide more comprehensive data on HyBryte’s safety and effectiveness. Importantly, key elements such as the patient inclusion and exclusion criteria and the primary endpoint are consistent between the two studies, which supports the integrity and comparability of the trial outcomes.

An estimated 80 patients will be enrolled at clinical sites in both the United States and Europe. This multinational approach is intended to support broad regulatory submissions and clear the way for HyBryte’s commercial launch on a global scale. With enrollment on schedule, Soligenix expects to report top-line results in 2026. These data could significantly strengthen the case for HyBryte to become the first approved front-line treatment for early-stage CTCL. As Soligenix continues to advance this promising therapy, FLASH2 represents a potentially transformative milestone in the company’s efforts to address a long-standing unmet medical need within the rare disease and oncology communities.

Trial Results Reinforce HyBryte’s Promise

Soligenix’s HyBryte has reached a key milestone with the successful completion of its first phase 3 clinical trial, known as the FLASH study, delivering statistically significant positive results and marking a major step forward in the treatment of early-stage cutaneous T-cell lymphoma (CTCL). Recognized for addressing a critical unmet medical need, HyBryte has been granted orphan drug designation in both the United States and European Union, along with Fast Track status by the FDA.

In contrast to many existing CTCL therapies that often require a year or more to demonstrate effectiveness, HyBryte produced statistically meaningful clinical responses in only six weeks. Continued treatment further increased efficacy, with response rates climbing to 40% at 12 weeks and reaching 49% at 18 weeks. Importantly, the therapy proved effective across both surface-level patch lesions and deeper plaque lesions, a distinction that sets it apart from many current early-stage CTCL treatments, which tend to show efficacy primarily in patch-type disease. This broader impact across lesion types underscores HyBryte’s differentiated potential in managing this heterogeneous and challenging condition. The structure and outcomes of the study reinforce the promise of HyBryte as a practical, noninvasive therapeutic option that could redefine care for CTCL patients.

HyBryte also stands out for its strong safety and tolerability profile. Results from the FLASH trial showed very few adverse events, which is a notable advantage compared to other CTCL treatments that can cause significant short- and long-term side effects. This makes HyBryte especially well-suited for older patients who may be dealing with other health issues and are particularly sensitive to treatment-related complications.

Another innovative feature of HyBryte is its use of visible fluorescent light rather than traditional ultraviolet (UV) light for activation. This approach eliminates the carcinogenic risks that are commonly associated with conventional phototherapy, providing a safer treatment experience while preserving therapeutic efficacy. The activation of synthetic hypericin by safe, visible light enhances both safety and convenience for patients. Taken together, the results from the FLASH and ongoing FLASH2 studies establish HyBryte as a compelling front-runner to become the first approved primary treatment for early-stage CTCL, offering a faster-acting, safer, and more comprehensive alternative to existing standards of care.

Safety and Market Potential Align

One of HyBryte’s most important strengths in the treatment of cutaneous T-cell lymphoma (CTCL) is its consistently favorable safety record, as demonstrated across several clinical trials. In contrast to many currently approved therapies for early-stage CTCL, which are frequently linked to serious or even life-threatening side effects, HyBryte has shown excellent tolerability with no safety issues reported so far. Its unique mechanism of action does not involve DNA damage—an important advantage in a therapeutic space where numerous treatments pose risks such as melanoma, other forms of cancer, significant skin injury, and accelerated skin aging.

This strong safety profile takes on even greater importance given that existing CTCL treatments are only sanctioned for use after other options have failed, and none are approved for initial, front-line use. In such a landscape, safety considerations weigh heavily in treatment decisions, especially for older patients who may also be managing other medical conditions. HyBryte’s properties, including low systemic absorption, its nonmutagenic active compound, and the use of visible, non-carcinogenic light for activation, set it apart as a particularly safe and practical option. With no first-line therapies currently available, HyBryte is well positioned to fill that critical gap by combining safety with clinical effectiveness.

Beyond its strong therapeutic potential, HyBryte also presents a substantial commercial opportunity in a market that remains largely underserved. Analysts estimate the global CTCL treatment market to exceed $990 million, highlighting the significant demand for innovative and effective therapies. As clinical development progresses, HyBryte has the potential not only to transform outcomes for patients but also to emerge as a new standard of care in CTCL management, meeting urgent clinical needs while offering a scalable solution for healthcare providers and investors alike.

Advancements in Oncology Research

The world of pharmaceutical research is continually evolving, and recent announcements from several key players in the biopharma space highlight significant progress. From promising clinical trial results to strategic partnerships aimed at broadening market reach, these developments offer new hope for patients and clinicians alike.

Amgen Inc. is reporting results on its phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6). According to the company, the trial met its primary endpoint of overall survival (OS) at a prespecified interim analysis. The company noted that “bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive.” Gastric cancer is the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and more than 650,000 deaths globally each year, highlighting a critical unmet medical need. 

Amicus Therapeutics Inc. recently announced the publication of a post-hoc analysis of data from the ERT-experienced cohort of the PROPEL study. The study evaluated cipaglucosidase alfa-atga + miglustat (cipa+mig) in adults with late-onset Pompe disease (LOPD). The report was published in “Muscle and Nerve.” In this new publication, based on a within group effect-size analysis, subjects who switched from alglucosidase alfa to cipa+mig achieved improvements or stability in most of the outcomes measured.  

Tonix Pharmaceuticals Holding Corp. is reporting the publication of a paper in the peer-reviewed journal “Cancer Cell.” The paper, titled “A CXCR4 Partial Agonist, Improves Immunotherapy by Targeting Immunosuppressive Neutrophils and Cancer-Driven Granulopoiesis,” represents a collaboration between scientists at Tonix and Columbia University’s Medical School and presents data demonstrating that treatment with murine TNX-1700 (mTNX-1700) increased survival and decreased metastases in animal models of gastric cancer.  

Citius Oncology Inc. announced the execution of a distribution services agreement with Cencora (formerly AmerisourceBergen), a global pharmaceutical services company. This agreement marks another significant step forward in the company's commercial launch strategy for LYMPHIR (denileukin diftitox-cxdl), its FDA-approved immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL). This new agreement expands Citius Oncology's commercial distribution network, providing additional access and product availability upon launch. The agreement with Cencora, a leader in specialty pharmaceutical distribution and services, builds on a previously announced distribution services agreement to support long-term scalability and market reach of LYMPHIR. 

These recent developments underscore the dynamic and hopeful landscape of cancer treatment. From innovative therapies showing promise in clinical trials for conditions such as gastric cancer and late-onset Pompe disease, to strategic commercial moves ensuring that approved treatments like LYMPHIR can reach patients more effectively, the biopharmaceutical industry continues to push the boundaries of what's possible.  

For more information, visit Soligenix Inc. 

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